EDF Health

Selected tag(s): Significant New Use Rule (SNUR)

When will EPA fully explain and legally justify its reviews of new chemicals under TSCA?

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D.is a Lead Senior Scientist.

Over two years have passed since EPA published its first, highly controversial New Chemicals Decision-Making Framework.  This document attempted to lay out major changes EPA was making, in response to relentless industry pressure, to its reviews of new chemicals entering the market.  Prior to this, EPA had been conducting reviews that largely conformed to the new requirements for these reviews that Congress included in the reforms to the Toxic Substances Control Act (TSCA) enacted in June 2016.

Among the many concerning aspects of EPA’s new approach were its herculean efforts to avoid finding a new chemical “may present an unreasonable risk” or that the information available to EPA is insufficient to permit a reasoned evaluation of the chemical.  Under reformed TSCA, either of those findings requires EPA to issue an order – as specified under section 5(e) of TSCA – that restricts the chemical, requires testing, or both in a manner sufficient to ameliorate the potential risk.

One of EPA’s new tactics was to illegally bifurcate its review of a company’s “intended” uses of the new chemical from other “reasonably foreseen” uses.  The company would get the coveted unfettered approval to enter commerce, based on an EPA review limited to its intended uses; these approvals take the form of EPA issuing a finding that the chemical is “not likely to present an unreasonable risk.”  Any review of other reasonably foreseen uses would be relegated (if it took place at all) to a later, wholly separate process that would only be triggered if EPA also promulgated a so-called “significant new use rule” (SNUR).  Under such a SNUR, a company seeking to engage in a reasonably foreseen use of the chemical EPA identified would be required to first notify EPA, who would then conduct a review of that new, now “intended,” use.

These SNURs are often referred to as “non-5(e) order SNURs” because they do not follow from EPA’s issuance of an order under section 5(e) – indeed, avoiding such orders was the whole point.  We have previously addressed the many problems – legal, policy, and scientific – with this approach; see for example, here and here.  These include:

  • the failure to assess all intended and reasonably foreseen uses of a new chemical at the same time, as required by TSCA and necessary to consider the potential for people to be subject to multiple exposures; and
  • the inability to require testing of the new chemical substance using a SNUR, which can be required through an order.

EPA held a public meeting and took public comment on its 2017 Framework at the time it was published.  But it never responded to the many comments it received criticizing its framework.  And when EPA was sued over its use of the Framework, it dodged the suit by claiming it was not using the Framework (see p. 14 here), leading to the lawsuit being withdrawn.  (Later in this post below we discuss that EPA has in fact been repeatedly using the core feature of the Framework.)

Meanwhile, hundreds of decisions made with no public framework

EPA has never made public any subsequent description of its decision-making approach or justification for it, despite the hundreds of new chemical approvals it has been cranking out ever since.  EPA has also never responded to the numerous public comments it received criticizing its framework.

Frustration over this situation led to a Congressional call for EPA to publish and then take comment on an updated description of its new chemicals review process.  Last January, EPA Administrator Andrew Wheeler made a commitment to Senator Carper to publish a revised new chemicals framework that would specify: “(i) the statutory and scientific justifications for the approaches described, (ii) the policies and procedures EPA is using/plans to use in its PMN reviews, and (iii) its responses to public comments received,” and to provide opportunity for public comment on the revised framework.

Last month EPA announced that it will hold a “Public Meeting on [the] TSCA New Chemicals Program,” which is to take place tomorrow, December 10.  However, while the agenda includes a speaker who will provide an “overview” of what EPA is now calling its “working approach,” EPA’s announcement indicated it would not release any actual document before the public meeting; instead, it will do so “by the end of the year.”  And while the meeting agenda provides for “public feedback” at the end of the meeting, the lack of any document to respond to will surely limit the ability of the public to provide meaningful input.

Absent such a public document, the rest of this post will provide our best understanding of how EPA has been reviewing new chemicals over the last two years, based on our scrutiny of each such decision.  Read More »

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Trump EPA caves again to industry demands on new chemicals, and workers pay the price

Richard Denison, Ph.D.is a Lead Senior Scientist.

Isocyanates are nasty chemicals, including when they are left over as residuals after manufacturing other chemicals.  Here are the kinds of risks they pose, according to the National Institute for Occupational Safety and Health (NIOSH):

Isocyanates are powerful irritants to the mucous membranes of the eyes and gastrointestinal and respiratory tracts.  Direct skin contact can also cause marked inflammation.  Isocyanates can also sensitize workers, making them subject to severe asthma attacks if they are exposed again. There is evidence that both respiratory and dermal exposures can lead to sensitization.  Death from severe asthma in some sensitized subjects has been reported.

In prior reviews of new chemicals under the Toxic Substances Control Act, EPA has repeatedly indicated that “[i]socyanate exposure has been identified as the leading attributable cause of work-related asthma, and prevalence in the exposed workforce has been estimated at 1-20 percent.”

Both NIOSH and EPA have raised even greater concern over activities involving spray application of chemicals containing isocyanates.  In 2006, NIOSH issued a rare alert calling for workers to undergo medical surveillance and wear high-efficiency respirators and gloves when engaged in such activities.

Even in the recent past, when reviewing new chemicals containing isocyanate residuals, EPA has typically (1) issued a consent order subjecting the company submitting the chemical for review to multiple conditions in order to limit workplace inhalation exposures to the residuals, and (2) followed up with a Significant New Use Rule (SNUR) that extends those conditions to other companies, requiring them to notify EPA prior to engaging in any activity that exceeds those workplace limits.  And the only case since TSCA was amended in 2016 where EPA found a new chemical “presents an unreasonable risk” – as opposed to the more common, lower-bar finding that it “may present an unreasonable risk” – involved residual isocyanates present after manufacture of two new chemicals.

In such cases EPA has imposed some combination of three types of conditions on manufacture of such chemicals:  prohibitions on activities that could generate inhalable forms of the chemical and result in inhalation exposures; strict requirements for the use of high-efficiency respirators and gloves; and a strict limit on the amount of isocyanate residuals allowed to be present in the new chemical, typically in the range of 0.1% to 0.2%.

So it is quite disturbing to see how EPA has dealt with the most recent such new chemical for which EPA has issued its final decision – which requires that companies employ NONE of these protections.  Read More »

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PART 1: Busting industry-perpetrated myths about new chemicals and worker protection under TSCA

Richard Denison, Ph.D.is a Lead Senior Scientist.

Part 1          Part 2         Part 3

This week the House Energy & Commerce Committee held a hearing on EPA’s failures to protect workers from chemical risks.  It featured a number of compelling testimonies from worker representatives:  auto workers, firefighters, teachers, and farmworkers.  It also featured testimony from a former Occupational Safety and Health Administration (OSHA) official, who made the case for why it is so critical that the Environmental Protection Agency (EPA) comply with the mandates and use the enhanced authorities Congress gave the agency under the Toxic Substances Control Act (TSCA) to protect workers exposed to chemicals.  He detailed why OSHA is unable to do so, describing OSHA as “outmatched” and having “exhausted its capacity” in the face of decades of severe budget cuts and limited legal authority.

The chemical industry is perpetuating damaging myths about worker protection at EPA and OSHA, which have unfortunately taken a firm hold in the Trump EPA.

Unfortunately, the hearing also included testimonies from two chemical industry representatives who painted a highly deceptive picture of what EPA has done to protect workers under the new TSCA and the adequacy of OSHA regulations regarding chemical risks in the workplace and the extent of compliance with them.  This and future posts will address the damaging myths these witnesses are perpetuating, which have unfortunately taken a firm hold in the Trump EPA.

Myth #1:  EPA is committed to protecting workers when reviewing new chemicals under TSCA.   Read More »

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Need more evidence of the chemical industry’s bad faith on TSCA? Read this.

Richard Denison, Ph.D.is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

This story is about chemicals known as chlorinated paraffins.  They are used as flame retardants, plasticizers and lubricants, among other things.  They come in three main versions:  short, medium, and long-chain.  Short-chain chlorinated paraffins (SCCPs) have been banned or are set to be banned in a number of jurisdictions and are listed for elimination under the Stockholm Convention.  The U.S. is not a party to Stockholm and has not banned SCCPs.  However, in 2012 EPA secured agreement from their leading domestic manufacturer, Dover Chemical Corporation, and their leading importer, INOVYN (formerly INEOS Chlor Americas, Inc.), to phase them out in consent decrees issued to settle enforcement actions EPA had brought against the companies (more on that later).

Concern over the medium and long-chain variants (MCCPs and LCCPs) has been significant and growing, however.  This is because they, like SCCPs, are expected to be very persistent and very bioaccumulative (vPvB) and, given evidence of systemic toxicity as well as toxicity to aquatic and terrestrial organisms, are also expected to be PBTs (persistent, bioaccumulative, and toxic chemicals).

The regulatory history of chlorinated paraffins under TSCA has been long and taken numerous, often troubling, turns.  We’ll only touch on some highlights here.   Read More »

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Have we learned anything in the last 4 decades when it comes to allowing chemicals like PCBs onto the market?

Richard Denison, Ph.D.is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

The Science section of today’s New York Times reports “Killer Whales Face Dire PCBs Threat” – more than four decades after Congress largely banned PCBs (polychlorinated biphenyls).

Concentrations of the chemicals in the blubber of orcas living in waters off the coasts of industrialized countries remain high, and new research indicates the contamination presents an existential threat to the survival of these populations.

Reading the article brought to mind concerns we have raised in recent comments to EPA on proposed rules it has issued for new chemicals under the Toxic Substances Control Act (TSCA).  Read More »

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The TSCA new chemicals mess: A problem of the chemical industry’s own making

Richard Denison, Ph.D.is a Lead Senior Scientist.

Nary a day goes by without a complaint being lodged by someone in the chemical industry, or in one of the myriad law firms that represent its interests in Washington, D.C., about the delays in EPA’s approval of new chemicals under the Toxic Substances Control Act (TSCA).

Here’s the irony:  Those delays and the general chaos in the TSCA new chemicals program are entirely of the industry’s own making.   Read More »

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